Minutes for Generic HL7 SPL Sub Team May 5, 2009 1. Are you ready for SPL R4? What have you done to get ready?
We need your participation! One company reported that they have purchased software.They are currently training on it.The software is also being validated.They should be ready to go in July. Some notes from the discussion: Q1:If you have an inactive component and no UNII for it, what should be done?Is the UNII required for inactives? Regarding this, several questions were raised for Lonnie Smith at the FDA
May these be submitted without the inactive components?And if they are submitted without inactives, how is the update done after submission?
Will drug listings validate if there are inactive components without UNIIs?Will a manual process be involved? Or will the submission be routed back to the sponsor because of validation issues?
The conclusion from the meeting was to not include the inactives until the UNIIs were available.This still leaves the questions about the update. Another sponsor has submitted NDC Labeler Code and our Drug Establishment information to FDA using the XFORMS for those pieces and it has been accepted and their 2009 Registration is shown on the Establishment/Registration pages. As for the Content of Labeling and Drug Listing, they attempted to use XFORMS for this for testing purposes only on several occasions and it was a disaster. Not user friendly and the user manual is awful. They still don’t know what happened to the content of labeling text that they entered, saved and then wanted to see again for editing purposes… couldn’t locate the text anywhere when they opened the form back up. They are going to continue to use the same software that they have been using for their SPL/PLR labels. There is a major upgrade to the software that will cover the R4 initiative.
2. New D&B service:
Has anyone used it? If so, how did it go? There was no feedback on this.
3. New Validator that FDA sent out.
Has anyone tried it? There were several responses.The new validator is sensitive. Examples were raised:
Title containing the ampersand rather than the word 'and'
case sensitivity
Also it was mentioned that running the validator successfully did not guarantee FDA will accept the listing
4. Inactive ingredients:
Are all necessary? They are requested but not required.See discussion above in item 1.
5. SPL R4 Press Release:
GPhA sending out to members. Informational – no discussion
6. Virtify webinar this week:
Jeffery to give information.Jeffery sent out the invitation that he had seen.This was sent out a day before the webinar in ‘pre-minutes’.Jeffery attended and has slides for anyone who is interested.It was a good basic intro to SPL R4.It was vendor-sponsored but not vendor-centric.
7. Name changes questions:
As with most name changes there is a grace period of converting the labeling components. As such, if the labeling has not changed yet, the re-submission of the Labeler Code form may be premature. It would be good to review the labeling change timeline and base the re-submission decision upon that information. Informational – no discussion
8. Other issues. A participant brought up an issue they had run into.They uploaded a label for a container andreceived an error message.The label can’t be seen it; it seems not to be attached.The FDA doesn’t see it either.It was suggested that this may be a reference issue in the XML. Is putting an image in with non standard LOINC OK? – Reed Tech suggests no; the principal display panel (PDP) section is what is requested for the image. What about the image of the carton? Reed Tech says they want to see whole carton; and PDP needs to contain the text of the customer facing panel.Intagras disagrees saying that this is recommended, not required. Another issue was raised regarding the same product under 2 labeler codes (sponsor and partner – different NDCs and companies) - One CoL exists.Does there need to another drug listing/CoL or no? Reed Tech’s understanding is as follow: Regarding the scenario where a product is manufactured and marketed by Company X and also sold to Company Y who simply sells the same product with a different NDC label (i.e., relabeler), it is my understanding… ·Company X must submit an SPL-Labeler Code Request, SPL-Establishment Registration, and SPL-Listing/Labeling. ·Company Y must submit an SPL-Labeler Code Request, SPL-Establishment Registration, and SPL-Listing/Labeling. Note that upon agreement, Company X may submit Company’s Y SPLs on their behalf. ·From the FDA Implementation Guide (3.1.1 ) and Instructions document (4.6.8), Company Y’s SPL-L/L can refer to the source NDC Product Code. Here is the snippet of applicable XML code using the <asEquivalentEntity> element: <manufacturedProduct> <code code="1234-5678" codeSystem="2.16.840.1.113883.6.69"/> <name>product name<suffix>name suffix</suffix> </name> <asEquivalentEntity classCode="EQUIV"> <code code="C64637" codeSystem="2.16.840.1.113883.3.26.1.1"/> <definingMaterialKind> <code code="3333-4444" codeSystem="2.16.840.1.113883.6.69"/> </definingMaterialKind> </asEquivalentEntity> Where: 1234-5678 = relabeled NDC Product Code product name = relabeled proprietary product name 3333-4444 = source NDC Product Code What about a sample label?This is similar to above and maybe should be a reviewer question. The question of export was raised again regarding an export only pharmaceutical. Unresolved. Attendees
May 5, 2009
1. Are you ready for SPL R4? What have you done to get ready?
We need your participation!
One company reported that they have purchased software. They are currently training on it. The software is also being validated. They should be ready to go in July.
Some notes from the discussion:
Q1: If you have an inactive component and no UNII for it, what should be done? Is the UNII required for inactives?
Regarding this, several questions were raised for Lonnie Smith at the FDA
- May these be submitted without the inactive components? And if they are submitted without inactives, how is the update done after submission?
- Will drug listings validate if there are inactive components without UNIIs? Will a manual process be involved? Or will the submission be routed back to the sponsor because of validation issues?
The conclusion from the meeting was to not include the inactives until the UNIIs were available. This still leaves the questions about the update.Another sponsor has submitted NDC Labeler Code and our Drug Establishment information to FDA using the XFORMS for those pieces and it has been accepted and their 2009 Registration is shown on the Establishment/Registration pages. As for the Content of Labeling and Drug Listing, they attempted to use XFORMS for this for testing purposes only on several occasions and it was a disaster. Not user friendly and the user manual is awful. They still don’t know what happened to the content of labeling text that they entered, saved and then wanted to see again for editing purposes… couldn’t locate the text anywhere when they opened the form back up. They are going to continue to use the same software that they have been using for their SPL/PLR labels. There is a major upgrade to the software that will cover the R4 initiative.
2. New D&B service:
Has anyone used it? If so, how did it go?
There was no feedback on this.
3. New Validator that FDA sent out.
Has anyone tried it?
There were several responses. The new validator is sensitive.
Examples were raised:
- Title containing the ampersand rather than the word 'and'
- case sensitivity
Also it was mentioned that running the validator successfully did not guarantee FDA will accept the listing4. Inactive ingredients:
Are all necessary?
They are requested but not required. See discussion above in item 1.
5. SPL R4 Press Release:
GPhA sending out to members.
Informational – no discussion
6. Virtify webinar this week:
Jeffery to give information. Jeffery sent out the invitation that he had seen. This was sent out a day before the webinar in ‘pre-minutes’. Jeffery attended and has slides for anyone who is interested. It was a good basic intro to SPL R4. It was vendor-sponsored but not vendor-centric.
7. Name changes questions:
As with most name changes there is a grace period of converting the labeling components. As such, if the labeling has not changed yet, the re-submission of the Labeler Code form may be premature. It would be good to review the labeling change timeline and base the re-submission decision upon that information.
Informational – no discussion
8. Other issues.
A participant brought up an issue they had run into. They uploaded a label for a container and received an error message. The label can’t be seen it; it seems not to be attached. The FDA doesn’t see it either. It was suggested that this may be a reference issue in the XML.
Is putting an image in with non standard LOINC OK? – Reed Tech suggests no; the principal display panel (PDP) section is what is requested for the image.
What about the image of the carton? Reed Tech says they want to see whole carton; and PDP needs to contain the text of the customer facing panel. Intagras disagrees saying that this is recommended, not required.
Another issue was raised regarding the same product under 2 labeler codes (sponsor and partner – different NDCs and companies) - One CoL exists. Does there need to another drug listing/CoL or no?
Reed Tech’s understanding is as follow:
Regarding the scenario where a product is manufactured and marketed by Company X and also sold to Company Y who simply sells the same product with a different NDC label (i.e., relabeler), it is my understanding…
· Company X must submit an SPL-Labeler Code Request, SPL-Establishment Registration, and SPL-Listing/Labeling.
· Company Y must submit an SPL-Labeler Code Request, SPL-Establishment Registration, and SPL-Listing/Labeling. Note that upon agreement, Company X may submit Company’s Y SPLs on their behalf.
· From the FDA Implementation Guide (3.1.1 ) and Instructions document (4.6.8), Company Y’s SPL-L/L can refer to the source NDC Product Code. Here is the snippet of applicable XML code using the <asEquivalentEntity> element:
<manufacturedProduct>
<code code="1234-5678" codeSystem="2.16.840.1.113883.6.69"/>
<name>product name<suffix>name suffix</suffix>
</name>
<asEquivalentEntity classCode="EQUIV">
<code code="C64637" codeSystem="2.16.840.1.113883.3.26.1.1"/>
<definingMaterialKind>
<code code="3333-4444" codeSystem="2.16.840.1.113883.6.69"/>
</definingMaterialKind>
</asEquivalentEntity>
Where:
1234-5678 = relabeled NDC Product Code
product name = relabeled proprietary product name
3333-4444 = source NDC Product Code
What about a sample label? This is similar to above and maybe should be a reviewer question.
The question of export was raised again regarding an export only pharmaceutical.
Unresolved.
Attendees
Generic Sub Team Leader
OTC Team Coordinator
Distribution only
Generics Sub Team Co Leader
Distribution list only